NDC codes

FDA NDC Directory
Product NDC (as listed)72189-494Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0494Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
72189-494-30721890494307218904943030 TABLET, FILM COATED in 1 BOTTLE (72189-494-30)Marketed from Jun 22, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Ropinirole
Generic name (nonproprietary)
ropinirole
Active ingredients
Ropinirole hydrochloride — 1 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Direct_RxNDC labeler code 72189
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079229
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 72189-494_2c4e39ee-1b28-61c5-e063-6394a90aeef5SPL ID 2c4e39ee-1b28-61c5-e063-6394a90aeef5SPL set ID febd4b37-6039-5522-e053-6394a90a855fRxCUI 314208UNII D7ZD41RZI9
Pharmacologic class
Nonergot Dopamine Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472189049430 followed by a unit qualifier and the quantity

Package 72189-0494-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-494

What is NDC 72189-494?
72189-494 is the product NDC for Ropinirole, Ropinirole hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ropinirole.
What is the active ingredient?
Ropinirole hydrochloride.
Who is the labeler?
Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ropinirole?
110 other product NDCs are listed under this name. See all Ropinirole NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ropinirole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-413868788-4138-03
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260272162-2602-0372162-2602-09
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260372162-2603-0372162-2603-09
RopiniroleRopinirole hydrochloride 6 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260472162-2604-0372162-2604-09
RopiniroleRopinirole hydrochloride 8 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260572162-2605-0372162-2605-09
RopiniroleRopinirole hydrochloride 12 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260672162-2606-0372162-2606-09
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25064850-0250-30
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25164850-0251-30
RopiniroleRopinirole hydrochloride 6 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25264850-0252-30
RopiniroleRopinirole hydrochloride 8 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25364850-0253-30

All 111 Ropinirole NDCs

Other NDCs under ANDA 079229

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 079229
ProductStrengthForm · routeLabelerProduct NDC
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7445
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralBionpharma Inc.69452-356
RopiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralBionpharma Inc.69452-357
RopiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralBionpharma Inc.69452-358
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralBionpharma Inc.69452-359
RopiniroleRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralBionpharma Inc.69452-360
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralBionpharma Inc.69452-361
RopiniroleRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralBionpharma Inc.69452-362
RopiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4318
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2515
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2793
RopiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9653
RopiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9656
RopiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2200
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralASCLEMED USA INC.87063-198
RopiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralASCLEMED USA INC.87063-199
RopiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralASCLEMED USA INC.87063-200
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralASCLEMED USA INC.87063-201

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